Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy

Sponsor

University of Oklahoma (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05921253

Collaborator

(none)

104

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to determine if low level vagus nerve stimulation will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in study participants' blood.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Lymphoma	Device: PARASYM TENS unit Device: PARASYM TENS unit (Placebo)	N/A

Detailed Description

Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.Prospective, randomized, sham controlled, double-blinded study of low-level tragus stimulation vs. sham treatment.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Self administration of Low Level Tragus Stimulation (LLTS; Placebo) PARASYM TENS unit will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.	Device: PARASYM TENS unit (Placebo) Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a different position of one ear compared to the "experimental arm" for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study. Other Names: Placebo
Experimental: Self administration of LLTS PARASYM TENS unit will be placed in a pre-determined position (different from that of the placebo) of one ear for 1 hour every day for 14 days.	Device: PARASYM TENS unit Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a preset position of one ear for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study. Other Names: Experimental

Arm

Intervention/Treatment

Placebo Comparator: Self administration of Low Level Tragus Stimulation (LLTS; Placebo)

PARASYM TENS unit will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.

Device: PARASYM TENS unit (Placebo)

Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a different position of one ear compared to the "experimental arm" for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study.

Other Names:

Placebo

Experimental: Self administration of LLTS

PARASYM TENS unit will be placed in a pre-determined position (different from that of the placebo) of one ear for 1 hour every day for 14 days.

Device: PARASYM TENS unit

Patients with breast cancer or lymphoma who have undergone chemotherapy for their disease, will have tests to determine heart function. Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to a preset position of one ear for a period of 1 hour for 14 days. After approximately 14 days, patients will have the same tests that they had at the beginning of the study.

Other Names:

Experimental

Outcome Measures

Primary Outcome Measures

Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS) [2 weeks]
An echocardiogram will be performed on patients at baseline and at follow up (14 days after start of intervention). The percentage change of GLS and left ventricular ejection fraction (LVEF) will be compared at baseline and follow up in patients receiving cardiotoxic chemotherapy.

Secondary Outcome Measures

Effects of LLTS on autonomic tone [2 weeks]
Measure change in autonomic tone by 15-minute Heart Rate Variability at baseline and follow up. (2 week) HRV has time and frequency domain numbers that are continuous variables from 0-100 and more.
Effects of LLTS on oxidative stress [2 weeks]
Analyze markers of oxidative stress in serum collected from patients at baseline and at follow up. Serum will be analyzed by DCF assay for endothelial oxidative stress before and after use of the TENS device. Results are expressed in Units - continuous variable.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients (>50 years) with breast cancer or lymphoma, who have received anthracycline-based therapy (a cumulative dose of ≥ 200 mg/m2 Doxorubicin or bioequivalent dose of other anthracyclines) and/or HER2 antagonists within the last 60-90 days and have

= 1 of following additional criteria:

previous chest radiation,
type 2 diabetes mellitus,
hypertension,
current smoking,
obesity (BMI ≥ 30),
previous myocardial infarction or
established atherosclerotic heart disease.

Exclusion Criteria:

atrial paced rhythm,
history of seizure currently on treatment,
history of vasovagal syncope,
end stage liver or kidney disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

University of Oklahoma

Investigators

Principal Investigator: Tarun W. Dasari, MD, MPH, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oklahoma

ClinicalTrials.gov Identifier:

NCT05921253

Other Study ID Numbers:

OU-SCC-NCAN

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Oklahoma

Stimulation Device

Vagus Nerve Stimulator

Study Results

No Results Posted as of Jun 27, 2023